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RECARBRIO(imipenem, cilastatin, and relebactam) for injection(四)
2019-07-18 11:59:00 来源: 作者: 【 】 浏览:10659次 评论:0
in should not receive RECARBRIO unless hemodialysis is institutedwithin 48 hours. There is inadequate information to recommend usage of RECARBRIO for patientsundergoing peritoneal dialysis.
Imipenem, cilastatin, and relebactam are cleared from the circulation during hemodialysis. For patientsmaintained on hemodialysis, administer RECARBRIO after hemodialysis and at intervals timed from theend of that hemodialysis session.
2.3 Preparation of RECARBRIO Solution for Intravenous Administration
RECARBRIO is supplied as a dry powder in a single-dose vial that must be constituted and further dilutedusing aseptic technique prior to intravenous infusion. To prepare the infusion solution, contents of the vialmust be constituted with the appropriate diluent as instructed below. A list of appropriate diluents is asfollows:
 0.9 % Sodium Chloride Injection, USP
 5 % Dextrose Injection, USP
 5 % Dextrose Injection, USP + 0.9 % Sodium Chloride Injection, USP
 5 % Dextrose Injection, USP + 0.45 % Sodium Chloride Injection, USP
 5 % Dextrose Injection, USP + 0.225 % Sodium Chloride Injection, USP
RECARBRIO has low aqueous solubility. To ensure complete dissolution of RECARBRIO it is importantto adhere to the following instructions:
Step 1) For diluents available in 100 mL prefilled infusion bags, proceed to step 2. For diluents notavailable in 100 mL prefilled infusion bags, aseptically withdraw 100 mL of the desired diluent andtransfer it to an empty infusion bag, then proceed to step 2.
Step 2) Withdraw 20 mL (as two 10 mL aliquots) of diluent from the appropriate infusion bag andconstitute the vial with one 10 mL aliquot of the diluent. The constituted suspension is for intravenousinfusion only after dilution in an appropriate infusion solution.
Step 3) After constitution, shake vial well and transfer resulting suspension into the remaining 80 mLof the infusion bag.
Step 4) Add the second 10 mL aliquot of infusion diluent to the vial and shake well to ensure
complete transfer of vial contents; repeat transfer of the resulting suspension to the infusion solution
before administering. Agitate the resulting mixture until clear.
Constituted solutions of RECARBRIO range from colorless to yellow. Variations of color within this range
do not affect the potency of the product.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Discard if discoloration or visible particles are
observed.
The above instructions for preparation of RECARBRIO solution for intravenous administration must be
followed for all patients, irrespective of the intended patient’s renal function. The volume of this prepared
RECARBRIO solution to be administered to patients is determined based on renal function [see Dosage
and Administration (2.4)].
2.4 Preparation of RECARBRIO Solution for Intravenous Administration in Patients with Renal
Impairment
For patients with renal impairment, prepare a reduced dose of RECARBRIO (1 gram, 0.75 grams, or 0.5
grams) [see Dosage and Administration (2.2)] by preparing a 100 mL solution containing 1.25 grams (as
described above in Section 2.3) then withdrawing and discarding the excess according to Table 2.
Table 2: Preparation of Reduced RECARBRIO Doses for Intravenous Administration in Patients
with Renal Impairment
Creatinine
Clearance
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